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A Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU (Carmustine) in Patients With Metatstatic Melanoma

Phase 2
18 Years
Not Enrolling
Melanoma (Skin)

Thank you

Trial Information

A Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU (Carmustine) in Patients With Metatstatic Melanoma


I. Determine the objective clinical response rate and duration of response in patients with
unresectable locally recurrent or metastatic melanoma treated with O6-benzylguanine and

II. Compare the toxicities of this regimen in patients with no prior chemotherapy vs prior
chemotherapy failure.

III. Correlate clinical response to this regimen in these patients with O6-alkylguanine DNA
alkyltransferase (AGT) depletion and baseline AGT in peripheral blood mononuclear cells and
tumor tissue.

OUTLINE: This is a multicenter study. Patients are stratified according to prior
chemotherapy (chemotherapy failure vs chemotherapy naive).

Patients receive O6-benzylguanine IV over 1 hour, followed 1 hour later by carmustine IV
over 1 hour on day 1. Treatment continues every 6 weeks for a minimum of 2 courses in the
absence of disease progression or unacceptable toxicity.

Patients with disease progression are followed every 6 months. All other patients are
followed every 3 months for 1 year.

Inclusion Criteria


- Histologically proven unresectable locally recurrent or metastatic melanoma

- Chemotherapy naive with no more than 2 prior immunotherapy regimens (including
cytokines, vaccines, or adjuvant interferon) OR

- Prior chemotherapy failure with no more than 2 prior immunotherapy regimens
(including adjuvant interferon) and no more than 1 prior chemotherapy regimen
(which may include carmustine) not including antiangiogenesis therapy

- Measurable disease

- At least 20 mm in at least 1 dimension by conventional technique OR at least 10
mm in at least 1 dimension by spiral CT scan

- No disease confined only to the CNS

- No uncontrolled symptomatic brain metastases regardless of other disease sites



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks


- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,200/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 mg/dL

- AST and/or ALT no greater than 3 times upper limit of normal

- PT normal


- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min


- DLCO at least 70% predicted


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No concurrent significant psychiatric or medical illness, including active
infections, that would interfere with study therapy or increase risk

- No other malignancy within the past 5 years except curatively treated nonmelanomatous
skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer



- At least 4 weeks since prior systemic chemotherapy (at least 6 weeks since prior
carmustine or mitomycin) and recovered

- No other concurrent chemotherapy or investigational antineoplastic drugs


- At least 2 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy


- At least 3 weeks since prior major surgery and recovered


- At least 4 weeks since other prior anticancer systemic therapy and recovered

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Thomas F. Gajewski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Food and Drug Administration

Study ID:




Start Date:

June 2000

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma



University of Chicago Cancer Research Center Chicago, Illinois  60637
Ireland Cancer Center Cleveland, Ohio  44106-5065
Loyola University Medical Center Maywood, Illinois  60153
Lutheran General Cancer Care Center Park Ridge, Illinois  60068
Evanston Northwestern Health Care Evanston, Illinois  60201
University of Illinois at Chicago Health Sciences Center Chicago, Illinois  60612
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne, Indiana  46885-5099
Oncology/Hematology Associates of Central Illinois, P.C. Peoria, Illinois  61602
Central Illinois Hematology Oncology Center Springfield, Illinois  62701
Michiana Hematology/Oncology P.C. South Bend, Indiana  46617
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Mercy Ireland Cancer Center Canton, Ohio  44708